FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company...
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.
FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for first-in-human clin...
